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Research Review

Collection and use of human data for research requires the appropriate regulatory approval. The Code of Federal Regulations, 21 CFR Part 11, 50, and 56, describes the requirements for clinical trials involving human subjects with respect to data and review. The UC Davis Health Compliance Department provides oversight for the use of Protected Health Information (PHI). Researchers who wish to receive PHI from the medical record and do not have an IRB-approved protocol must obtain permission from the Compliance Office and supply this to the CTSC Biomedical Informatics team to begin the process.

Research preparation application (Staff Only)Required to obtain permission to review PHI in preparation for a research project. Do not use if you intend to use the data for publication or for recruitment activity.

Decedent research application (Staff Only)Required to obtain permission to use PHI for decedent research when no identifiers are linked to living persons.